510(k) K153324 ยท LNH System, Nuclear Magnetic Resonance Imaging
Ingenia 1.5T and Ingenia 1.5T S R5.2
| Applicant | Philips Medical Systems Nederlands B.V., Best Noord-Brabant, NL |
| Decision | Substantially Equivalent, Mar 22, 2016 |
| Received | Nov 18, 2015 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K153324
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2024 | Philips North America Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system Open, Classified |
LNH | None listed |
| Aug 11, 2021 | Philips North America Llc Ingenia 1.5T S-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orien Completed |
LNH | None listed |
| Feb 22, 2019 | Philips Medical Systems Nederlands Ingenia 1.5T S, Model Number 781347. Nuclear Magnetic Resonance Imaging System Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.